*BYETTA is not indicated for the management of obesity, and weight change was a secondary endpoint in clinical trials.

Important Safety Information for BYETTA (exenatide) injection

Contraindications

BYETTA is contraindicated in patients with prior severe hypersensitivity reactions to exenatide or to any of the product components.

Warnings and Precautions

Never Share a BYETTA Pen Between Patients Pen-sharing poses a risk for transmission of blood-borne pathogens, even if the needle is changed.

Acute Pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been reported. After initiation, observe patients carefully for symptoms of pancreatitis. If suspected, discontinue promptly and do not restart if confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis.

Hypoglycemia Increased risk of hypoglycemia when used in combination with a sulfonylurea (SU) or when used with glucose-independent insulin secretagogues (eg, meglitinides). Clinicians may consider reducing the SU dose in patients receiving BYETTA to reduce the risk of hypoglycemia. When used with insulin, evaluate and consider reducing the insulin dose in patients at increased risk of hypoglycemia.

Renal Impairment Should not be used in patients with severe renal impairment or end-stage renal disease. Use with caution in patients with renal transplantation or when initiating or escalating the dose in patients with moderate renal failure. Postmarketing reports of altered renal function, including increased serum creatinine, renal impairment, worsened chronic renal failure, and acute renal failure, sometimes requiring hemodialysis and kidney transplantation.

Gastrointestinal Disease Because exenatide is commonly associated with gastrointestinal adverse reactions, BYETTA is not recommended in patients with severe gastrointestinal disease (eg, gastroparesis).

Immunogenicity Patients may develop antibodies to exenatide. In 3 registration trials, antibody levels were measured in 90% of patients, with up to 4% of patients having high-titer antibodies and attenuated glycemic response. If worsening of or failure to achieve adequate glycemic control occurs, consider alternative antidiabetic therapy.

Drug Interactions

Oral Medications: BYETTA slows gastric emptying and can reduce the extent and rate of absorption of orally administered drugs. Use with caution with medications that have a narrow therapeutic index or require rapid gastrointestinal absorption. Oral medications dependent on threshold concentrations for efficacy, such as contraceptives or antibiotics, should be taken at least 1 hour before BYETTA.

Warfarin: Postmarketing reports of increased international normalized ratio (INR) sometimes associated with bleeding with concomitant use of warfarin. Monitor INR frequently until stable upon initiation or alteration of BYETTA.

Use in Specific Populations

Pregnancy: Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

INDICATION

BYETTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Not a substitute for insulin and should not be used in patients with type 1 diabetes or diabetic ketoacidosis.

Concurrent use with prandial insulin has not been studied and cannot be recommended.

Not studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis.

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Indication and Important Limitations of Use for BYETTA

BYETTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Not a substitute for insulin and should not be used in patients with type 1 diabetes or diabetic ketoacidosis.

Concurrent use with prandial insulin has not been studied and cannot be recommended.

BYETTA has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, based on postmarketing data. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using BYETTA; consider other antidiabetic therapies for these patients.

Adults with type 2 diabetes on insulin glargine alone or in combination with metformin and/or a TZD were enrolled in a 30-week, randomized, double-blind, placebo-controlled clinical study to receive either BYETTA (n=137) or placebo (n=122) in addition to titrated insulin glargine. In both arms, under investigator guidance, insulin was titrated to achieve a targeted fasting glucose level of <100 mg/dL using the Treat-to-Target algorithm. Upon adding BYETTA to insulin glargine, patients with an A1C ≤8% were instructed to decrease their insulin glargine dose by 20%; patients with an A1C >8% maintained their current insulin dose. Patients receiving BYETTA were titrated from the 5-mcg dose to the 10-mcg dose after the first 4 weeks.1 Please see full Prescribing Information for full dosing algorithm.